Label: V34 TOOTHPASTE. TABLETS.- v34 toothpaste tablets tablet

  • NDC Code(s): 83812-005-01
  • Packager: LLRN PERSONAL CARE(SHENZHEN)CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 24, 2023

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  • Active Ingredient

    Sodium Bicarbonate 7%

    Phthalimidoperoxycaproic Acid 6%

    Hydrated Silica 5%

  • Purpose

    Whitening, Fresh Breath, Clean mouth

  • Use

    Place tablets in your mouth.
    Chew until it foams.
    Brush your teeth as usual. Use twice daily.

  • Warnings

    Prouducts is not intended for use by children.
    Do not swallow.

  • Do not use

    Pregnant woman and children under 12 years old.

  • When Using

    Do not swallow foams.

  • Stop Use

    Stop use if you feel unwell or nausea.

  • Ask Doctor

    Call a POISON CENTER or doctor/physician if you feel unwell for an extended period of time afer use.

  • Keep Oot Of Reach Of Children

    Keep Out Of Reach Of Children

  • Directions

    Place tablets in your mouth.
    Chew until it foams.
    Brush your teeth as usual. Use twice daily.

  • Inactive ingredients

    Microcrystalline Cellulose, Maltodextrin, Mannitol, Malic Acid, Sodium Carbonate, Calcium Carbonate, Xanthan Gum, Sucralose, Magnesium Stearate, Aroma, Acid Red 33, CI 42090, Methyl Diisopropyl Propionamide

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    V34 TOOTHPASTE. TABLETS. 
    v34 toothpaste tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83812-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C) (PHTHALIMIDOPEROXYCAPROIC ACID - UNII:5OEJ6FAL6C) PHTHALIMIDOPEROXYCAPROIC ACID6 g  in 100 
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE7 g  in 100 
    HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9) HYDRATED SILICA5 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    AROMADENDRIN (UNII: 7YA4640575)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    MALIC ACID (UNII: 817L1N4CKP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83812-005-0130 in 1 BOTTLE; Type 0: Not a Combination Product11/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/24/2023
    Labeler - LLRN PERSONAL CARE(SHENZHEN)CO., LTD (419890311)
    Establishment
    NameAddressID/FEIBusiness Operations
    LLRN PERSONAL CARE(SHENZHEN)CO., LTD419890311label(83812-005) , manufacture(83812-005)
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